yep. >> what you're seeing on that screen there, the yellow line is basically what nih has had as far as our purchasing power for research. it's the appropriation, but as adjusted di the eded by the effects of inflation inflation. the dotted green line was the projection going back to 1970 until 1998 with the wonderful doubling and we have been getting up doubled ever sense. follow the dotted green line, and we stayed on that trajectory, we would be higher up in the neighborhood of over $40 billion. >> so just to get back on track, and to reverse damage of the last decade, nih, if i'm right, needs more than $12 billion in just the first year? the house proposal does not even put that much in over the space of five years? so let me just ask based on what you've got here, in your expert judgment, what's annual rate of increase that nih needs to get

back on track on its funding? >> well, first, let me say we were thrilled, also to see what's in the 211st century cure, it's the $2 billion a year of mandatory, gave a great jolt of excitement and some relief to a community that's. really quite stressed over the last 12 years as we lost ground but to get back on a stable trajectory that would result in a healthy biomedical research ecosystem, which our country depended on with great success over 50 years, i estimate in my professional judgment, we need to be in the space of inflation plus 4% or 5% a year. that's pretty much that dotted line plus inflation plus 3.7% i guess, a healthy way to make sure all the talent and capabilities of this country in terms of biomedical research, where we led the world for decades, would be sustained, encouraged, and innovation going forth in the ways we want it to. >> thank you, dr. collins. $it $2 billion a year for five years

is better than nothing, but not pretend that a small temporary investment billions of dollars short of what we need to do the job, there is gaping holes in our nih budget, and we need a serious plan to fix it. there are many ways to make that happen. i have a medical innovation act for example, that could add another $6 billion in a year not costing taxpayers a dime, but whatever we do, this committee has to get serious about medical innovation, and that means we have to do better than the house proposal on this. thank you, mr. chairman. >> thank you senator warren. senator whitehouse. >> thank you, mr. chairman. let me start by echoing the chairman's interest in having a review of where we are on health information technology. i read with interest by your predecessor, and i think it

makes a lot of sense and provides, i hope, bipartisan foundation, for us to work forward, and i think that the meaningful use program is obsolete and needs to be tuned up to meet new challenges that the progress over the last year since it was past now present to us, so thank you for agreeing to work with the chairman and the committee on the four or five key goals that we should be achieving and i would urge you to think big in accomplishing that. let's no tweedle around the edges. let's get this right. dr. collins, to follow up on what senator warren was saying, i'm interested in what you've been able to document by way of consequences. for failures toed adequately

fund our scientific and medical research. it strikes me that you can tell me there's a return on investment from the research that we do and if we don't fund the research, we lose that return on investment. it strikes me, also, that you have examples of human benefits from scientific research if fore gone become human costs, and you pay attention to the country's global competitiveness in this field so if you can comment in the three areas on what you think is the payback for investment in scientific research, or contrarily the

cost of not funding scientific research? >> well i very much appreciate the opportunity to talk about some of those consequences. just put up another graph which, in many ways reveals the difficulties that are present in this country beginning back in 2003. i'm showing you the opportunity that an investigator who comes to nicsh with the best ideas gets funded. most research done in the country with the nation's finest universities and institutes are supported by nih. this is the main place where the work gets done. for most of our history, that's been in the space of 25 to 30% success rate, one in three. that's not easy. that means two-thirds of the people are sent away. now it's one in six. that's very unhaemtealthy. we look at what happened in the past when we funded up to 30%. there's a lot of great science falling in between that space. we're not funding that now, half

of what we should be supporting by historical trends is left on the table. so we don't know what we're missing in that regard the next great idea about cancer may have been one of the things that did not quite make the cut. in terms of the question about medical consequences, i'm a physician. the reason i love being at nih and love what we do is to hope this is going to change things for the better for people's health, and our track record there is striking in terms of what happened, in terms of longevity and prevention of disease, and it is frustrating we are going slowly. i promise you the institute directors and i, when we sit around the table to figure out what to do in the constrained circumstances, we prioritize and try to push forward. we're just going slowly. we need more advances in cancer. we need a universal influenza vaccine, we need those things, but we could be going faster. >> in terms of documents, it's returning $2.20 in the first

year to the local economy because of the goods and services generated as a result. we support 400,000 jobs directly across the country in all 50 states on basis of the grants given out. those are high quality jobs. you asked about global competitiveness. we were the up question leader of the world in the research until recently. that's not longer to be taken for granted. when you see our losing ground, and we see countries like china, india india, singapore, and south korea upping their investments sometimes in double digits, we are losing that. >> quick question on that. when they make increases in investments, do they have an eye on us as a target to beat us? >> you bet they do. >> or doing it in a regime way? >> it's a little of both. they read our playbook from 20 years ago, and they saw what it did for america's economy and for the spinning off of small businesses that come out of this effort, and they want to do what we did, and so i don't know if you'd say they are gunning for us, but they are basically trying to learn from our experience and recreate that in

their environment. one statistic that i think renders this is serious last year china filed more patents in bioscience than the united states did. that was not even a close competition a couple years ago, and they have now jumped ahead of us, and those patents result in intellectual property claims that are going to ultimately spin off new businesses. we have to take that seriously. >> thank you, chairman. >> does that mean china will start respecting patents more? >> i think i better not comment on that. >> don't get the man in trouble. >> yeah. >> senator thank you, senator whitehouse, senator baldwin? >> thank you, mr. chairman, and i very much appreciate you and ranking member holding this hearing, giving us the opportunity to learn more about the administration's precision medicine initiative. we're excited about it because

it's life saving potential, we're excited about it because it's break through potential, and i'm excited about it being the honor of representing a state that's been a leader in setting the stage for some of the things we're talking about today and precision medicine from the isolation of the first end bree yopmbryonic stem cells to the discovery of repeat clippics, which is major discovery with a big impact on the study of human genetics, and the clinic developed a very significant genetic biobank, one of the larger ones with information from over 20,000 central wisconsin residents. dr. collins, i know you've been asked reit rations of the

questions before by my colleagues on the committee, but i -- if you have -- if you have more to add, i'd like to hear more how to utilize existing data and data i described collected by the clippic and real world clinical data. how will you use those and share those in new ways to create personal idahoedized onal idahoedized personal idahoedized therapies? >> yes, they are a wonderful leader in the enterprise and visited there several times myself and dr. murray brilliant, the person there overseeing the large cohort and precision medicine effort is something we are all looking to for his experience to share with us, and he was at the white house when the president announced this on january 30th. in the workshop we're going to hold at the end of this month at vanderbilt, we're going to look hard at the ways in which mayo,

and perhaps million veterans project as well, could in fact, be asassembled, not doing all the work from scratches but making the sum greater than the whole part. this initiative builds power by numbers, and that's one of the reasons we're so excited about being able to say that word "million" which was not in the vocab of most people planning these things until fairly recently. we want to take every kind of opportunity to build on the experience that is already ob tabed in places. they found individuals who by looking at their dna sequence ought to be sick but they are not. >> right. >> so they have some kind of resilience. there is some people called genetic heros, something about them we have to understand because they have a resistance to disease that we perhaps could learn more about and share with other people by development of new therapeutics. that's one insight they have a

start on, but if you had a million people, you could find a lot more. >> i want to follow up on a discussion you had about the research work force, talking about funding and the reducing percentage of research grant applications that are funded. i'm curious to know what impact this initiative may have on the changing nature of the research work force. it strikes me that, you know, doctors who happened on discoveries of novel therapies in the course of treating patients and others don't know there's treatment that holds a reaction for a breakthrough in this field. what opportunities for you and nontraditional researchers are presented through this initiative? >> oh, senator, another great question, and glad you brought it up.

this initiative will not reach its full potential if it does not lure and recruit all kinds of people from different disciplines to get together to work on this. a parallel here with the human genome project i led where it was a historic opportunity, that people who never really thought of themselves as working in that space decided to make it their passion. i think the same can happen here. we would want to have computational experts because we have very large data sets, the world of big data in the best way. we want technology developers of all sorts who figure out ways not only to look at the dna sequence, but what about me tab lites floating in your system look at those in a given situation, all technologies we mention about mobile health with a lot of opportunities there as well, and physicians who can begin to figure out, how do you take this data and implement that in a real world setting to improve health outcomes?

you know, i say, when e look at how we practice medicine today compared to when i was resident medicine in 1980, it's not that different. we have such a long way to go here in terms of really incorporating new technologies coming along. this is going to be wonderful laboratory for all kinds of people to get involved and figure out what kind of discoveries can be made and what use can be put to them. i hope it's filled with that innovative talent. >> i appreciate that. mr. chairman, with your indull jens, one last question. there's incredible potential in what we talk about, but it strikes me that there is potential for fraud for folks as this develops, offering, selling fraudulent interventions that claim to be personalized med sip, and i would like and,

again, it can be after the hearing to hear from you more about how the fda works to prevent fraud and ensure patient safety in the age of precision medicine. >> i'll take a quick moment if it's okay just to say that -- >> senator murray and i would like to know the answer too. >> all right. well i think just beyond fraud the point of having a test out there that really does not work, and it's being sold, and this is one of the imptous in our deciding to actively regulate that subset of diagnostics and great tests out there, but there's bad tests out there, and let me give you an example, one that's in the presession medicine space, and there's several, though. there's kick six used for predicting people having coronary heart disease in response to a treatment. we have seen data on it. we saw the test did not work,

but laboratory tests are selling it. there was a med analysis of 19 clinical studies, the test does not work. then they performed a randomized on over 18,000 patients. the test does not work. when this was reported out around 2010, at that point, over 150,000 people got that test. we estimate the cost to the health care system was upwards of $2.4 billion, and that test is still available today. that does not serve patients well and it does not serve precision medicine well because that underminds our efforts to make sure we get accurate reliable meaningful tests out there and get the right treatment to the right patient. >> senator murray do you have further remarks? >> how are consumers supposed to know that? >> right now they can't.

they don't. you don't have the oversight. >> does that mean not have oversight for this? >> we do have the authority, and what we proposed is it's time for us to exercise it. years ago in the program laboratory developed tests were simple. they were used locally rare conditions, and so in setting up the program, we said we'd exercise enforcement discretion. subject to requirements were not end forcing them, and overtime without our being there, these tests are increasingly more complex, being used nationally, and becoming increasingly more important than being relied on for health care decisions, and as a result of that in our seeing some of the bad tests out there is why you move guard to regulate them, but i have to tell you this question' come up since the 1990s. we had nih then, saying the department of energy needed to be involved, institute of med sip came out in the 2000s to say that, two advisory committees to the secretary of health and human services. we've been trying to move

forward. in 2007, there was a guidance saying we'll regulate a sebset, and what we heard from the lab community was do not chip away at this put out an overarching frame work make it risk base, and phase in implementation. we held a public meeting in 2010. we got that input. the frame work proposed in late of last year was our attempt to do that, have a risk based program, try to balance innovation with patient safety and phase it in over a period of time and right now we're addressing comments working with the community on what the policy should be. >> you're engageingeing providers and groups as you work through that? >> yes. there's a lot of feedback, and working through the american cancer society seeing tests incorrect. people are diagnosed with cancer when they do not have it and people who have cancer are told they do not have cancer. they said we need better oversight here make sure we have accurate tests, and the tests do what they claim to do.

>> important question. one more. dr. collins why is one million the right number? >> well, it's a great question and there's nothing magic about one million other than it's a nice round number that we could aim for. i actually will admit i'd love to go beyond that. as i said a minute ago with conversation with senator baldwin, this is all about numbers and that's where you gets poir of analysis to see what works. million is ambitious. seemed like a goal we could set for ourselves to try to achieve but given the fact we already know there's cohorsets out there collectively enrolling more than a million people, if we figure out how to do it, we'll do better than that. >> listening to the committee members over the last few weeks, every one of our straits has -- we have fred hutch in my state developing a data base, so i don't know how you're going to work through all this to get it

but, again, diversity, represent everybody is really important. i'm going to look forward to hearing how you do that. >> i agree with you on that. if we just tact together the existing cohorts, we would not have the kind of representation we need of the country. >> thank you, thank you, mr. chairman. >> doctor, on your -- following up senator baldwin and senator murray, this was the high risk low risk difference you were talking about in the laboratory tests. you're focusing on the high risk areas, is that right? >> well, the high risk lower risk talking about earlier was on mobile -- on mobile technologies, but here too, we try to focus on -- when we implement this to focus on higher risk tests, and -- >> does any of your enforcement -- all prior approval, or is it where you

might be acting on a complaint? >> well -- >> in other words to let the marketplace run for a while on the lower risk items and place it in effect. >> yes, for the lower risk tests, we would not enforce riemplts on them other than tell us what they are and if there's problems reported. we would not perform tests on rare disorders, and, geng, some tests were unmet needs as well. >> well this has been very useful and said to senator murray, this is like going back to college. it's very interesting, and we're very privileged to be students in a classroom with such distinguished teachers and witnesses on an important subject that's so important, and one that the president, the house of representatives and this committee are all committed to working on. it is my hope and senator murray and i work on how to do this,

but it was my hope we can finish our work on innovation initiative this year and report it to the full senate early next year to be acted on and some schedule like that, we have other things to do as well, but the precision medicine proposal by the president would be incorporated with that, so it'll be a part of all of it. we did not talk about privacy today. who figures that out? >> very important question. onc, nih, and the white house ostp have been engaged in this. we'll have a deep conversation july 1st and second with the participants workshop that's coming. >> what we're talking, you're going to have a million participants or more use all the data, and you have to figure

out some way to protect that. >> yes. >> and we're deeply serious about doing that in the most high-tech, thoughtful, capable way with a fair amount of experience to bill on. we have to take that with great seriousness. >> and, doctor, i think you heard from a variety of senators, our interest in helping you figure out what the steps are to improve the electronic medical record system, real results, accords nate properly with whatever the defense department is doing. there's a lot of work there. we're not trying to catch anybody here, but trying to fix a problem, and we'd like to work with you to do that and to do it -- to do it soop because it affects many many physicians, many, many hospitals, and as we've heard today in a couple important ways, it's absolutely essential to the precision

medicine initiative. so there's no other -- i got a final page to read. hear record remain open for 10 days, summit additional information for the record within the time they'd like. i thank senator murray for the way she's conducted, help used too this in a bipartisan way learning more, and next hearing is tomorrow on higher education and the committee stands adjourn adjourned.

here's what we're covering on c-span3 wednesday. 10:00 a.m. eastern, a hearing on global health programs including testimony from elton journhn talking about his work with the aids foundation live here. 2:30 eastern, the senate small business committee looks at the effect of federal labor laws on seafood industry. watch both hearings live on c-span3 and cspan.org. the new congressional directly is a handy guide to the 114th congress with color photos of every senator and house member plus bio and contact information and twitter handles. also, district maps, a fold out map of capitol hill, and a look at congressional committees, the president's cabinet federal agencies, and state governors. order your copy today.

it's $13.95 plus shipping and handling at cspan.org. the legal case cementers on the question how much a defendant in the drug case needs to know about the law to be found criminally liable. the defendant in this case is challenging statutes spanning designer drugs not specifically banned under federal law by mimic effects of illegal narcotics. this is app hour. you'll hear argument this morning in mcfadden versus united states. mr. russell. >> mr. chief justice, may it please the court. we have narrowed disagreement and we all agree that the fourth circuit misconstrued the element for criminal offense under the

controlled substance analog act and agree the jury instructions given in this case were erroneous. instead, me and the government now agree to prove an offense they have to prove they knowingly distributed. we further agree the government does that by showing the defendant knew the substance in question had the characteristics that made an analog under the statute. we may disagree over the government's alternative here they that it can show the defendant knew the substance was illegal or regulated. if all the government means is illegal or regulated under the statute of conviction the control substances act itself we agree, but the government would lose because as acknowledged the evidence in this case showed that my client did not believe that his conduct violated the csa itself. >> just to make sure i understand all that you're agreeing on, you do agree if the defendant knew the substance was illegal under the controlled substances act or the analog act, even though the defendant did not know the chemical

structure or the particular effects, say that the dealer hand him a box and said this is our new analog, which is illegal under the analog act. you would agree that is sufficient for a conviction? >> we do agree with that and i think that that is simply a application of the general rule that the defendant have to know facts that make his conduct unlawful because he knows in that circumstance the only fact he needs to know. >> that stands sensible to me. what about the expert testimony from chemist? is that still put on in the trial? does the government still have to show put on an expert to say, well this is chemically modified, but it's substantially similar, and the jury sits there knowing they don't have to listen to this? how does that work? >> they have to show that because the government has to prove it is in fact an analog. >> does the jury have to understand chemical testimony? >> they have to make the

determination it is chemically similar. i acknowledge that's a lot to ask of a jury and a defendant. >> but it is the government's burden to show both compensation in relation to the substance and the effect of the drug? those, the government must prove, but what we have out of the way is that the defendant now does not have to go you agree, and the defendant does not have to understand the chemical structure? >> does not have to understand the chemical structure if the government proves the defendant knew the sub staps was illegal under the controlled substances act itself. >> well, the government is giving up a lot in this point, and i think you gave up a lot. your position that you have to know it's regulated under the chemical controlled substances act seems to me is contrary to the proposition that ignorance of the law is no excuse. if you didn't know i didn't know it was regulated, you'd say

he's innocent because he didn't know the law. i thought your position was that you do have to know as in all the other cases in the area the facts that make your conduct illegal. you don't have to know it's illegal? >> that's the principle position, but willing to say, however, whether you consider it a special exception to the rule or special application to the rule, if the government shows the defendant knows that the substance is illegal-under-par the statute of conviction, that serves the basic purpose of the knowledge of fact requirement. >> if he does not know, he's innocent? if he's ignorant of the law, he's not guilty? >> not guilty unless the government shows he knows the substance has the characteristics of an analog in which case is ignorance of the law is not an excuse. the government has two options. it can prove the fact knowledge, and the way this was described in staples and applied in other cases involving prohitted items. we're willing to acknowledge if

they can show he knew it was illegal under the statute, that's good enough. >> i take it it's the same under the control substances act itself, is that right? is that the analogy? you can either show the person knew it was heroin or you can show, well the person did not know it was heroin, but the person did know that it was some drug that was over schedule of a control substance? >> that's right. where we disagree with the government is it cop strews lower court cases that say that, saying the broader thing which is -- >> sorry -- you keep saying and knowing that it's illegal under the act. he doesn't have to know the act just know it is illegal that a law regulates it, otherwise he's not going to know what the number of the law is or the controlled substance act. >> i have to be clear --

>> criminals do not care. they just know or think it's something they just know it's a controlled substance. >> no. i would disagree with that. i think that's the principle of the agreement we have with the government here. it's not enough for the defendant to think it's illegal generally or unlawful under an import or state law. >> if he's selling without paying the sales tax, he knows that's illegal, enough to convict him under the controlled substances act. >> potentially that may be the argument. we give the example in the brief as somebody who knows he's selling cuban cigars in violation of an import ban. he knows, in this case that it's an illegal or controlled substance, but that knowledge does not equate. you do not say someone in the case knows he's selling a controlled substance because it turns out unbenoeps to him the cigars have marijuana to him. that's not the way you use the english language saying he knowingly sold marijuana or sold a controlled substance. >> take a case involving a drug

that's not analog, but listed in, and say that the facts are these, the distributor gives it to the person who is going to make the distribution and say this is an illegal drug, go distribute it. the person then goes and districts it and tries to evade law enforcement and so forth is caught. now, is it -- is that sufficient? is that evidence sufficient to take the case to the jury so the jury can find -- the jury can decide whether there's circumstantial evidence that person who distributed the drugs knew it was a controlled substance under federal law opposed to one of the few things that's illegal under state law, but not under federal law? >> there's sufficient evidence to go to the jury, and the jury then has to decide whether to make that interference. in a case like this where the he did not believe it violated federal law or the defendant was able to explain, yeah thought it was illegal because it was in violation of an import statute

then it's up to the jury to believe that, but if it does, it ought to conclude it was not established unless the government can show that the defendant knew characteristics of the sub staps that made it an analog. >> suppose the supplier tells the dealer, this substance produces exactly the same effect as cocaine. would that be enough to satisfy the requirement? >> not enough to satisfy. may be evidence from which the jury could draw interference that the defendant knew it was a controlled substance under federal law. i don't think that they should. i think it's only partial evidence. >> you say he has to know the chemical makeup that causes it to be an analog right? >> he either has to know that or has to know that it visits -- >> i understand. assume he does not know it violates the law. he also does not know that it -- what the chemical makeup is but knows what it is.

it is mvd 3. that's all he knows. now, under the control substance act, that's enough. he does not need to know the makeup of it, but know it's one theubstances. if indeed, md3 is an analog, why isn't that enough? that he just knows what it was and what it was is an analog. >> right. that's paralleled to someone knowing he has an ar-15 rifle which is, in fact, a machine gun. and that's not enough. you have to know the facts about the give up that make it analog, which is not the name. here it's -- >> this is not a rifle. this is in fact, a -- analog of a controlled substance. that's not a proper comparison. >> with respect -- >> he knows that it is -- he knows the identity of it, and that chemical is -- has in fact, the characteristics that

make it an analog. >> he knows knowing simply the name of it does not tell you whether it's analog or not. you don't know by knowing the name. >> well, that's true, and knowing that it's cocaine does not prove that you know it's a controlled substance. >> it does, though. because the only fact you need to know about cocaine for it to be a controlled substance is it is cocaine. that's the fact that makes it illegal. it's listed on the controlled substance act and the controlled substance schedules. if it's cocaine, you know what you need to know based on the presumption you know the law to know what you are doing is illegal. >> suppose the districter gives it to the perp to distribute it says, here, distribute this, there's a chemical formula on the container the chemical formula for pcp, whatever that is, c something, h something, and -- so that's all the person knows, knows exactly what it is the chemical forpewmuformula.

has he not committed a crime then? >> yes. i don't know depends how it is listed. the schedule could list the name. >> it does. >> so then you do not the fact that makes the conduct unlawful. >> but you don't know the person just arrived -- excuse me -- from mars and has no idea that that -- whether it's illegal or not. >> people know what the law is, know what's in the schedules, and if you know it's in the schedule and you know the fact, that's enough. i think -- >> what do you do with the actual facts of the case? that is the defendant gave names to what he called. he called it sweep you up -- now list ed listed -- supposed to be bath salts, but there's no bath samtlts

in the world that come in those packets, of course. so what -- what -- it's at a price that fits a controlled sub staps? >> i think what it reflects, what a jury finds it reflects, and truth of the matter is it shows the general thought he found a loophole to the federal drug laws as long as something was not in the schedules, even with drug-like effects, he could sell it at whatever price the market would bear. the government can point to that evidence to suggest that he knew his conduct violated the controlled substances act. >> i thought you said that evidence was enough to get you to the jury, right? >> yes. >> the defendant acted and sold these for incredibly inflated prices, and all of that is not

the thing itself, but it's evidence of the thing the government is trying to prove? >> that's right. it gets to the jury, but does not prove what the government has to prove, beyond a reasonable doubt. >> if i could understand, and i think, tell me if i'm wrong, the only thing possibly separating you and the government, see if it's separating you and the government, is the question of what happens if the defendant knew it was illegal under something other than the csa or the analog act, right? that's the only point of potential difference between you and the government? >> that's true with respect to the legal interpretation. i will say you ought not reach that because of the regulated status theory, reached on the merits in the court. >> wait a minute, yeah, you do differ with the government on that. >> yes. >> but assuming that the government cannot prove any belief in illegality, the government would not say it therefore must prove you knew

the chemical composition of what you were selling that you say you have to know the chemical composition composition. >> well we're on the same page, to be clear about the position i think that the only disagreement about the meaning of the law between the government and us now is the question of whether it's sufficient as a matter of law for the government to show that the defendant believe the substance was unlawful under some law other than the csa. they they that's sufficient. we think it's not sufficient. >> okay. >> beyond that -- >> assuming it's not sufficient, what else does the government have to prove? i think you differ on that. >> i don't think so. i think the government agrees that one way to prove the case is to show the defendant knew the characteristics of the substance that made it an analog. >> they agree -- >> when means the chemical composition? >> yes, yes. >> i'm sure -- okay. >> well -- >> who would that reach other than the chemist? the underground chemist being in the position to know that what

app ordinary person would not? >> i acknowledge the statute is straightforward and traditional reading has the effect of making it substantially harder for the government to prove that mens rea. >> my understanding is it would be enough if the defendant knew the name of the drug. whatever else, and if, indeed, that drug has the chemical composition. >> i won't -- i'm confident that that's not their position. >> okay. >> that they've said the opposite. >> so suppose the court instructs the jury that suffices if the defendant knows that this is an illegal drug because of the hallucination effect. >> i don't think --

again, the critical question is illegal drug, and if you mean -- >> illegal drug because of the effect. maybe that's incorrect because they have to be chemically the same so that's incomplete, but it seems to me that shifts the fight for mens rea. >> to be clear -- >> excuse me, and then it's shown that that is chemically similar. >> i think the court has to tell the jury that you can take into account the defendant's knowledge of the effect in deciding whether he knew it was illegal under the controlled substances act itself. what i'm quibbling with is the word "illegal," and i don't think it's sufficient if the jury was convinced the defendant thought it was an effect illegal under state law. that's why i was acting further. i don't think that a jury could, if it believed that, find the mens rea established also, eded unless, of course, they go under the prong

of the ordinary way which knowledge, unlawful possession of a prohitted item is proven. >> instruction page 14 with a brief on footnote nine, can you say that by adding a instance or two to the first paragraph? >> no or is it beyond hope? >> no, i think you'll recall this is setting forth elements, so i think the element is that the defendant has to know that he's distributing analog, and there's questions about ways in which to prove that. the court could give instruction of the sort they have to know, and that this is an analog, characteristics that make it analog within the meaning of the statute. have the government ask for instruction, could have begin instructions set or the government can show that the defendant knew the conduct was up lawful generally and make that or unlawful under the csa itself and reach cop collusions

based on circumstantial evidence including evidence concerning the defendant's knowledge about the drug's effect. but there's a world of zimpbsof difference saying this is circumstantial evidence whether the defendant knew he was violating the statute of conviction, and what the government's position is, which is once you prove that the defendant knows it's illegal at all, you're done, and the jury is compelled to prove mens rea is established. i think that's wrong. >> sorry to put you through it again, but it's important. we have to get it right. i understand your understanding that the sg -- the difference, you have to know it's illegal under any law. you say no under the csa. what was the other way in which you disagree with the government? >> i think that's the only way in which we disagree about the meaning of the statute. >> no, but i thought you disagreed about names and characteristics? >> well, this was -- >> i was disagreeing with justice

justice, and we have to know the chemical structure and effects of the analog because it's not enough to simply know its name. and so i don't think that we disagree with each other on that point. >> can i ask, mr. russell, about your difference as to whether it's-under-par this statute or under any statute? if you look at some of the instructions that are given just under the csa, not analogs, that some instructions just say you need to find that the defendant knew that he was distributing some kind of prohibited drug. they don't say a drug prohibited under the csa. using that as the analogy here that suggests that the jury wouldn't need to find the analog prohibited under the csa in the analog act, adjust that, knew it was prohibited by something. >> there's ambiguity in the

instructions whether it's up lawfulness generally or under the csa. i think courts, what they really mean is under the csa, and in the cases where the defendant is come forward and say, actually, it was illegal under some other statute, in, again, in hussein, in the case of morales three of the seven cases, the court said, no, that's not good enough. that makes complete sense. now, it could be that in a lot of cases the government is going to protect evidence that the government thinks is a controlled substance generally and agree they defer absent other evidence it's illegal under the csa itself but leave open the possibility that the jury can in a case like this say, now, the evidence does not show that he believe it was up lawful under the csa because hi looked at the schedules and believed if they were not on the schedules, they were not illegal. the only republican they are illegal if they are not in the schedule is the analog act.

prior to this case, i did not know. i think a lot of people didn't. in the community where my client was selling these things, they were sold openly in dgas stations, advertised in local newspapers and magazines. that's consistent with the fact that lots of people entertain the incorrect notion if something's not on the schedules, it's legal to sell, and -- >> ignoreance of the law is no excuse. if you're totally ignore rapt, if you know the chemical composition and that's on the analog act, they got you, right? >> no. i -- let me try to make clear my position. we agree that if the government can prove that you have the factual knowledge that the chemical has the characteristics that make it an analog, ignorance of the law is the excuse. >> well, wait, wait, wachltit. what does that mean? so i know all the chemical

characteristics, okay? i have to, in addition, know that those characteristics make it an analog? >> mo. >> okay. >> so there's three options one is that you propose, they know the name of the substance. >> right. >> we know the substance is chemically substantially similar to the controlled substance, and they know the fact that makes its possession unlawful under that. they have to know as well it's substantially similar and represented in actual facts. >> i'm not a chemist i know it's similar, but i know what the chemical composition is and i have to know that is substantially similar? i don't think so. >> yes. >> i think if i know the chemical composition and in fact it is substantially similar, they got you. >> i think we disagree on that, but if you take that view, we still win the case because there's no evidence they knew anything about the structure of what he was selling here. >> i assume your argument is

simply that it's a kind of coincidence. you have to know this substance is an analog. there's two ways you could know that. one way you could know it is you could know what the chemical composition of this is and what the chemical compensation of, say, cocaine is. that's one way. very few people other than a chemist know that. there is a second way you could know. second way you could know is that you know that it is forbid p en by a law with a title for bidding analogs, and if you happen to know it falls within that, of course you know it's an analog. because you know it falls within it. and those are the two ways. >> yes. >> no one's been able to think of a third. ignorance of the law is no excuse, has nothing to do with this case. this is just a coincidence, but those are two ways you could know it's analog. >> i agree those are the two ways to know it's analog.

and i don't think that the government can even argue that it satisfied that in this case much less that the justify would have. compelled to find that harmless reason. >> you say the government has to prove knowledge of two chemical compositions, the composition of what's being sold, but also the chemical composition of one of the items on the list of control substances? >> yes. yes. that is our position. that is -- >> only if that's the government's theory? only if the government goes that route rather than the route of saying it was analog? >> that is correct. >> you know, i will acknowledge that going the knowledge of identity route in the case is going to be difficult for nonchemists, but i think it's difficult for reasons that should not give the court pause other than it's difficult for someone to know, they know what the law is, whether what they are doing is illegal or not, and so, you know, our theory has the

benefit of voiding the problems we they are inherent. >> there's enough evidence in the case to go to the jury under instruction you want? >> yes. i agree there was. so the only question here is whether there should be a neutral under which we have another discussion with the district court about what the proper instructions are. i don't think we'll have a lot of disagreement about that or whether the court should, instead, hole it harmless. it's up fair too that in this case on the ground they did not present sufficient evidence to rebut a theory the government was not making in that trial. that's why we have forfeiture rules. the court resolves the case by saying here's the legal rule, two ways to prove it but the government in this case to the extent it has a special new theory about illegal under some other law waived that argument by failing to preserve it.

>> if i could reserve my time. >> thank you, counsel. >> thank you, mr. chief justice i find mr. russell is almost correct about the extent of the disagreement left in the case. our position is not that we can prevail if we prove the defendant believed that his conduct was illegal under some law other than csa or analog act. our position we prevail if we prove the defendant knowingly distributed a drug and believed conduct that distribution of the drug was illegal generally as the justice -- >> my question that i posed to him was really for you. >> would you mind repeating it? >> well i'll try. [ laughter ] suppose you have to show, and i think you do that the defendant did know it is an analog say the cocaine. there are two ways to do that. the first way is you could show this defendant, being a graduate in chemistry, knows what the

chemical composition of cocaine is knows what the composition of the other substance is, and knows they are the same. you're not going to be able to do that very often. >> right. >> another possibility is you can show that he knows that this particular substance is banned by a law that's called the app log act because, obviously, if he knows that it is banned by the act that bans analog, it must be analog. those are two ways you can prove knowledge. to prove it is banned by the antiturkey shoot act proves nothing about his knowledge this is analog, and, therefore, once you say, as you are trying to say, i think, that some other illegality is enough to convict, i no longer understand the argument. >> well, the argument, as justice pointed out in the real world, defendants do not tend to

know specific provisions of federal or state law, but they know whether what they are doing is illegal or not and our deal is knowing our intentional standard describes the culpable state of mind, and one way to prove that is to prove the defendant knowingly or intentionally engaged in the act. >> yes. but then you say the defendant does not have to know it's analog, and that i think you don't want to say. >> well -- >> because you can think it was banned in another act, and that makes you know that it is that thing that the other act bans. it does not show analog. >> what i'm saying is defendants believe what they are doing is illegal not under provisions but generally they believe it's illegal. >> that's not what the statute says. the statute does not say knowingly be a bad guy. it says knowingly manufacture distribute or dispense a controlled substance. >> yes. >> that's what the knowingly applies to. so you have to know it violates

that law, not just know you're a bad guy. that's not what it says. >> in almost every context easiest way to prove knowledge of the statute is prove the defendant knew the facts that made conducts illegal. >> right. >> what -- >> under the statute. >> but just to prove the facts, he does not have awareness of the statute, if he knows the fact including knowledge of structure and effects, that's usually in other context easiest way to prove knowledge under the kind of statute, and in this cop text that's not easy. there is another way. we think knowing our intentional standard described in the culpable mental staid and to prove knowledge -- >> how do you anchor the cuban sir gar that turns out to be filled with marijuana? >> well, i guess our primary submission is it's sufficient if the government proves that a deft distributed a drug and believed doing so was illegal

under a drug law, knowing it was an illegal drug law. >> you did not say this before. the brief -- has to be illegal urn some other drug law? >> the reason there's maybe not explanation in the briefs because there's a disagreement that became clear in the brief that we disagree with the courts of appeals and i can get to that in a sec, but, certainly, it's sufficient if the defendant believes what he's doing is illegal under a drug law distributing an illegal drug. it's consistent with the broader principles if the court held more broadly than that believing his conduct was illegal generally, and you don't have to go that far in this case and it's not fully briefed. >> that highlights what i think is the difference here. you got a defendant who is obviously, knows something's out there, trying not to do something, whether it's not to violate the csa or violate anything, and you just want to show to the jury, look something's bothering you. he knows that something's afoot

and that is all you want to prove opposed to he knows he's violating the csa or a drug law. >> well -- >> i don't know how that works. i understand how that works in this case because you just said to the jury, look, he's checking the schedule every day, doing this, and he's doing that. i'm concerned about extending that as a general matter where it does not have to be -- one, because i think it's not a question whether you know anything about the law at all, but whether you know the fact and whether that happens to bring it under the law. but then i don't know how broad the principle is that you just have to know what you're doing is -- raises a doubt in the jury's mind about whether you knew it was legal or not. >> two responses to point out to come back in case i don't get them through. i can give a real world example how it works in the csa context. this court held there's other ways to prove knowledge other than a defendant knew a critical fact, for example, the government can prove willful

blindness, and the court explained the republican you allow blindness to substitute for knowledge is not because being willfully blind is the same of knowing the fact, but the perp has the same state of mind as a person who knows the fact. we submit a person engaging in an act intentionally and believes doing that is illegal is as culpable if not more so than the person who knows all the facts that make his conduct illegal -- >> who is waveiving the sales tax law and you send him up the river forever 15 years? >> not in this case. it's sufficient if the government can prove that the defendant knowingly districted a drug believing it to be illegal to do so. whether or not he knew what provision of -- >> it's illegal because in fact, it's bad for animals and the law involved prevents veterinarians from using this kind of drug for app maltreatment. that's all he knows.

that's all he thinks. now, he's guilty of this statute? that does not tend to show at all that knowledge that he knows it's an analog but in your view because he feels guilty is perhaps he should, he's guilty of violates this law. >> well we believe that establishes the state of mind -- >> can you give my authority for that? i mean your example of willful blindness is an example of where, in fact, with respect to this law, he knows there is a risk he's violating in the conduct that it prepares, and he knows there's a serious risk, and he pays no attention to that. >> well -- >> that's not a very strong analogy, i don't think. >> well, i think what it shows is you don't prove actual knowledge of a fact to satisfy knowledge standard in the statute. it's sufficient for the court to hold in this case when the government proves a defendant is distributing an illicit drug for human consumption and believes what he's doing is illegal and

is correct about that, that's enough to satisfy the csa or analog act. >> might be, but there's evidence in this case different than what you are saying. he checked according to his brother. the controlled substance act did not see this listed. also, you know, he was told something was illegal, he flushed it down the toilet. why don't we leave this to the court below to figure out whether it was harmless or not given the evidence in the case. >> i acknowledge that is the court's usual practice. captions copyright national cable satellite corp. 2008 captioning performed by vitac

. [inaudible conversations] >> watch your step you. i will. [inaudible conversations] >> my name is telling smith. i am chairman of the board. world politics. is my pleasure to welcome you. the founder, and he heads the human rights and national affairs at the institute of world politics.

we have the privilege of having with us ambassador negroponte. i am not i am not sure whether i should address you as mr. ambassador or professor because i no that in addition to your role as a senior diplomat you are still have 1 foot in the. as you told me in the past your weekly trips to yell i went to school just up the street from their. but the but the same time you went to yale i was at trinity college. now i no you are running seminars at the respected jackson as to the yale. and so as chairman of world politics it is my privilege to welcome you here. it's if you ever get tired of that commute you have a home here.

at the institute we have a unique institution that was founded 25 years ago. in fact, we we will we will have a 25 year event on the 14th of october down to 25 years ago here with us also, chancellor and president right now. we provide education. not going to you through the details, details, but we have eight or nine major master degree programs, a student body and we are producing graduates who are going in the government commands of the military command to intelligence and serve in different aspects of government. i no you graduate from yale and join the diplomatic service. in the 80s in honduras.

my late father-in-law bill casey was there it's. i heard a lot of stories about what was going on in that part of the world. in the days immediately following you assume the role. i think you had already been confirmed but had not taken office yet as the united states representative to the united nations. somehow he had to find his way through something called the security council to get our activities per approved by the un command he did a wonderful job doing that. he did such a great job he gets into iraq as united states ambassador. and you did a wonderful job there. and right through your career seen how strong you were. you you became -- i guess you were the 1st director

of national intelligence. as director of national intelligence ambassador have the responsibility of coordinating 17 separate agencies who were part of what i'll call the intelligence community. i'm not sure that they were all agencies equally coordinated because they don't have their own spirit. let's put it that way. and now he has a similar role because probably a 3rd to a half a half of our intelligence apparatus today is probably coming out of the corporate world. and the national zero alliance coordinates and provides training for that corporate world and the ambassador is the chairman of the board's.

we welcome them and look forward to hearing your remarks. [applause] >> thank you. i you. i said bill because i was thinking about casey. your father-in-law who i used to welcome to honduras when i was ambassador. thank you, owen smith, very much for your kind introduction. i want to thank also matt daniels for having had the idea of organizing this -- organizing this discussion. i will make some are march the 20 minutes or half an hour or something like that about diplomacy and foreign policy and national security issues. then we will have a question-and-answer and then open it up to the audience.

but what i wanted to say is that diplomacy is really all the other public. i no it is sort of self-evident given what we all know about the diplomacy that was conducted by the founding fathers but it is important to recall it. on the 8th for the state department the portrait hanging on the wall at the very end of the ceremonial hall is the portrait of ben franklin we refer to as the father of american diplomacy and there was john adams thomas jefferson. these people were instrumental in gaining support for american independence. i don't think we can.to diplomatic achievements of quite such scope and

magnitude as was accomplished more than two centuries ago the support for independence the expansion of our territory thereafter once we became her public. i a republic. i was speaking to a group of 600 lawyers last -- this past saturday evening down in boca raton florida where they were having their annual outing. and a lot of them were in their real estate department of the law firm. you guys just don't know anything about real estate deals. think about the louisiana purchase. think about the acquisition of florida where we are standing at this very moment and think about seward's folly, seward's folly the $67 million purchase of alaska. again, that is really quite incredible diplomacy and

likewise the diplomacy of abraham lincoln's in helping to save our union men are flexing or not so fledgling, but early adulthood public was in dire straits and in severe danger of collapsing on itself. some pretty itself. some pretty good diplomacy was exerted in order to avoid countries like england coming in on the side of the confederacy when that was a real danger that particular time. so when people start telling you that the diplomacy you look at in the 19th century is about metternich and all those people answer to that is let's look at the diplomacy that we americans conducted ourselves during that century.

the next thing i would like to make a few comments on is the issue of leadership. niemi leadership our country are really that time of post- civil war after we averted the catastrophe of the union being divided and we had, by the way, a president who was really committed to the growth and very interested in our expansion westward in the construction of our transcontinental railroad. that is what he would have been doing had there not been a civil war. by 1870 we had become the largest, in terms of gdp the largest economy in the world. i think that is an interesting date to have

reached that status in the world economy because it is not beyond imagination of the country of china will become the similarly perhaps the largest country by gdp overall gdp. this is not an impossibility it took from 1870 about 40 years really tell the advent of the 1st world war before we began to play a global role commensurate with our economic strength. so it just causes me to wonder at what time china will be able to convert it's obvious economic strength that it has now into really effective global political action. i am not trying to venture prediction but our own national experience suggests

that this equation, if you will the translation from economic to political power is not necessarily automatic and it does not necessarily happen right away. there are other factors the commendably. in our case it was world war i. it was woodrow wilson. it was the role he played in helping bring the war to an end but regrettably the diplomacy of woodrow wilson who was very active. in fact he conducted too much of it himself but he negotiated the treaty of her sigh with the allied powers. as we all know 1st of all, we didn't -- wilson did not succeed in getting it ratified's by the senate in

part because he was ill at the time and just a sidebar about the presidency, but but that is not a job that is easy to conduct when he has serious health problems. he certainly he certainly have those at the time of the riverside debate. as. as a result, without us being in the system that was negotiated he really planted the seeds of the next war which brings us to franklin roosevelt's who succeeded in several major respects. first of all, and leading and leading our country to building the largest economic machine that had ever been known in the history of man just an absolutely extraordinary accomplishment to build the economy while also mobilizing some 16 million people.

he pursued a grand strategy in fighting the war that was nothing short of brilliant in terms of managing to lay our own actual entry into the fighting until such time as we really were ready to go in the action and not everyone particularly likes this fax, but by making a pact with the devil, if you we will joseph stalin in order to be recognized, a necessity that in order to be ever you had to align yourself with the soviet union at least during the time that we were actually in the emergency of fighting against the nazi regime. and then lastly and this is where he compares from a diplomatic.of view favorably with woodrow wilson he

really believed in preparing the postwar's. a lot more systematically and woodrow wilson had they did that right from the beginning and a lot of planners of the state department and the white house elsewhere working on the postwar system which of course resulted in the creation of the united nations and the bretton woods economic system both of which we more or less still operate under today although more about that subject a little bit later. and he had i think, the foresight and intelligence to insist, some people don't like it, but he insisted on having veto in the security council within the un charter because he said and judged correctly that

otherwise the congress would not once again have ratified yet another treaty charter ending yet another war. i think he felt that for congressional ratification there had to be a veto in the security council. that is how the charter was adopted. at the end of the war the united states economy was extraordinarily strong. we represented something like 50 percent of the global gdp. i would say i would say we had political influence around the world that was commensurate with that tremendous strength. i am not going to take you through volumes history, but the cold war then sort of challenge this postwar's order that have been established command it

happened quite fast. we did the cold war from 1947 to 19 91. there were a number of major regional conflicts during that time. most importantly korea. vietnam in afghanistan. we had we had close brushes a couple of times with nuclear exchanges. most especially in the cuban missile crisis when nikita khrushchev was foolhardy enough to send ships toward the island of cuba with nuclear missiles which was an irresponsible act on his part. with great skill the kennedy administration documented and written about in many different ways and makes for

fascinating reading. one of my favorite books is actually bobby kennedy's own account's of those events which was called 13 days. we had this close brush with nuclear exchange, but we got past it. then we moved into the post-cold war time which really started with the political transformation of eastern europe in 1989 in 1990 starting with poland and the fact that there was a polish pope who played an extraordinarily important role in canonizing the end of the cold war. then you have the collapse of the ussr at the end of 1991. and you just have to understand those of you who are not all the enough to have lived through that time

none of us professional diplomats believed this eventuality was possible. it's believe me, we were surprised. and a lot of people were surprised. and maybe a handful who can say that we had not lost faith that freedom could come to the eastern block and that the berlin wall could come down but but i think you can count them pretty much on the fingers of one hand ronald reagan, jean kirkpatrick was one a number of others. dick walters. >> dick walters, right. but i think you would agree with me that they were in a minority. there were those who really just reconciled the perpetual alley of the cold war division. thank goodness it did not

turn out that way. and so from that day forward we no longer viewed events around the globe through the prism of east-west rivalry's and went through a time in the 1990s where we thought of ourselves and it was articulated by madeleine albright as the sole remaining superpower. the clinton administration also exercise an option for a peace dividend, a reduction of defense expenditures and a reduction of expenditures for national security but that time was relatively short-lived and we woke up to the rude shock of the events of september 11 the ensuing so-called global war on

terrorism which really governed our respective our perspective on world affairs ' for half a dozen years or so and included mounting pretty large expeditions into afghanistan and iraq. a time in which i had a chance to work myself. i had -- i got called back to government service by the bush administration. i i have been retired and ended up doing for different jobs during the eight years of the bush and ministration actually, i was not confirmed until after september 11 because my nomination of been held up for irrelevant political reasons. i was about to have a meeting on the 12th. it's of course they canceled my hearing he had left and

months earlier. that friday night i was confirmed by the entire site by voice vote. so having been delayed and waited desperately to get a hearing and interact came onto the agenda fairly early on. and with the change of administration in 2,009 there was a deemphasis.

but all the while maintaining a pretty robust counterterrorism policy if you we will counterinsurgency policy to try to build the iraqi and afghan nation's. less emphasis on that. probably the next time frame if you will and perhaps the one we're in now is the arab spring and its sequel it would be the next watershed starting with tunisia. and since and since then i think the social and political unrest has really -- and violence has struck the middle east with a vengeance. egypt, syria, libya and now human. the political turbulence has been compounded by the sunni

extremist terrorism whether isis or al qaeda. both in the middle east or in the adjacent area of africa. that is to say al qaeda. that has been one of the trends that has occurred's, the movement of this extremist activity from the middle east to parts of africa and of course it continues pretty much unabated in parts of south asia. now, while all this is going on and this nonstate actor activity that we have been experiencing, we cannot neglect the fact that they are rising powers.

we talked about the united states having been represented 50% of the global gdp back in 1945. we 1945. we don't represent that anymore today. maybe something more approximating 20 percent. and there are other important rising nations starting to emerge from that situation back in the early 1970s. i have the opportunity to go to china with henry kissinger back in june of 1972. i been watching developments in china ever since. i remember 1979 only established relations i was serving, had just moved overlay 79 early aided to have early 80s to the east asia bureau. i remember as debating about what we were going to import we recognize china, lifted the embargo and were all

scratching our heads. we all chocolate that question today. how can we stop buying quite so much china. it seems to be one of the questions that people have. i think the important.is that from 150 years of weakness and they consider humiliation in many different situations where the opium wars or whatever example you choose special concessions for the european powers in china it's a country that has come back to its own. if you read dr. kissinger's book, a, a very thorough history of china from the us perspective, he makes the.that back in 17th and 18th centuries china's economy was perhaps the largest in the world. in a way for them they are going back to what they may

have considered a normal situation to were 300 years ago where as i think we sometimes still have a certain amount of disk -- difficulty intellectually and emotionally adjusting to the fact that china is almost a peer of hours in the economic realm and may someday in terms of its economic strength surpass the united states at least in overall terms. obviously it's been a long time if ever the other rising power, rising of course it was an important power before, but i would cite russia. with the with the collapse of the soviet union and we talked about earlier russia went through a time in the

1990s were it was -- it felt very weekend, it felt like the west in general treated russia treated russia as a defeated power and use that terminology. and there was and there was a time in the 1990s when the russian economy that so we can there economy was. the oils covers and gas discoveries in russia and secondly higher prices not taking into account what we will happen in recent times. you have to think of it also as a rising power.

that part of her three to five free trade network. we have to take into account as we formulate foreign policies and strategies in the years ahead. so where does this leave us today? we were a fledgling republic in the 1st half of the early 19th century. we were the leader undisputed leader of the free world pretty much through the entirety of the 20th century they are coming off of a pretty good record. the question is what will be all in place in the 21st century. i don't presume to be able to answer that question with

any degree of certainty, but i will try to answer it with a certain degree of confidence. it seems to me that it's really have a lot of things going. i want to mention while the more intangible ones 1st. very resilient and have a very creative and inventive and innovative economy. this is something that is the envy of just about any of the country in the world whenever we try to organize exchanges with another country exchanges between students over there over here one of the 1st things that people ask for especially if there entrepreneurs is how do i

instill the sort of silicon valley mentality and our students? 's had he teach entrepreneurship innovation i'm sure it can be talk to a., but i am not certain that it also doesn't have to do with the very conditions in which our society operates through human freedom and the ability of everybody the greater opportunity for people to maximize their potential. that is one important factor. we still are and i'm sure will continue to be the strongest economy in the world and our recovery from the financial crisis has been as good if not better than any other. we have a military capacity

that is unequaled around the world. so even though we're now at 20 percent of the global economy, i was thinking about it the other day, if you take just our allies basically europe, japan, korea and had the strength of there economy stars your back up to the 50 percent i was talking about in 1945. we helped of those coaches back to the situation in which they are. we have a slightly different distribution the network of free trading relationships.